Clinical Operations Manager, Kinevant

Kinevant Sciences, a wholly-owned subsidiary of Roivant, is focused on developing new therapies for rare auto-immune diseases, initially targeting sarcoidosis with an anti-GM-CSF monoclonal antibody (namilumab). The Company has recently initiated a Ph 2 clinical trial in pulmonary sarcoidosis. Sarcoidosis is a multi-organ autoimmune disease with poor treatment options that affects up to 200,000 people in the U.S. The long-term vision for Kinevant is to successfully develop and commercialize namilumab for sarcoidosis and potentially other inflammatory orphan diseases, as well as in-license other promising drug candidates for orphan autoimmune and inflammatory diseases.

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision:  launched over 20 portfolio companies (Vants); 6 FDA approved medicines; 5 successful IPOs; >$8B in global pharma deals and partnerships; pipeline of over 40 assets across various modalities and therapeutic areas; 8 consecutive positive phase 3 readouts since 2019.  Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.

The position duties are as follows: Responsible for front-line management and oversight of clinical operations activities and ensuring timely and adequate documentation of the Vant’s clinical trial(s). This role includes oversight of monitoring activities, identifying and escalating ongoing risks and ensuring operational deliverables are documented. Day-to-day job duties include:

• Provide eTMF oversight;
• Review QC Clinical Monitoring trip reports to identify trends in CRA performance, site issues or deviations, and work with individual CRAs and/or the CRO to understand root causes for trends in data quality;
• Monitor progress of identified findings through resolution;
• Review On-Site Visit Tracker/CTMS Export (Site Management);
• Escalate findings to Operations Management or Quality as appropriate;
• Update and compile clinical study metrics for review and escalation as appropriate;
• Review pre-screening Log Activities and drive sites to update documentation;
• Oversee Temperature Excursions for Investigative Medicinal Product;
• Coordinate and facilitate clinical document revisions (plans, memos, notes to file);
• Communicate and provide sponsor contact to study sites;
• Participate in any training meetings and train CROs/vendor staff as required;
• Perform User Acceptance Testing for EDC/PROs;
• Provides support to Clin Operations team as needed; and
• Oversee and monitor CT.Gov/PRS submissions and updates.

The position requires a Bachelor’s Degree in Healthcare Decision Analysis, Biology, Chemistry, a closely related life sciences degree, or foreign equivalent, followed by 3 years of experience in any occupation involving clinical operations in the pharmaceutical, biotechnology, or diagnostics industry in an FDA-regulated environment. Experience must include:

1. 3 years of experience with CRO operations management in various therapeutic indications within the Research and Development (R&D) Industry
2. 3 years of experience performing clinical operations management for different phases of clinical trials;
3. 3 years of experience performing data management or database programming within a regulatory environment;
4. 3 years of experience managing clinical study vendors and  overseeing vendor activities and deliverables (such as EDC, IRT, ECGs, PFTs, etc.), including but not limited to identifying and tracking key vendor metrics in order to identify and anticipate issues and facilitate root cause investigations for issue resolution or escalation
5. 3 years of experience drafting and implementing the site-specific patient recruitment plan(s) to ensure enrollment goals are achieved 

Full-time telecommuting is permitted. Individuals will be required to work during regular business hours in their local time zone. Requires travel 1x/quarter for approx. 3-5 days each trip domestically to locations on the East and West Coast. Confirmed locations are San Diego and NYC, additional locations confirmed with 3 month’s notice.

Resumes to hr@kinevant.com. EOE.